Striving to Quit-Wisconsin Tobacco Quit Line

Smoking Cessation Clinical Trial

Official title:

Striving to Quit: Wisconsin Tobacco Quit Line Tobacco Cessation Research

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01569477
• Other study ID #: 2012-0198
• Status: Withdrawn
• Phase: N/A
• First received: March 30, 2012
• Last updated: December 5, 2016
• Start date: September 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates when they are offered to Medicaid BadgerCare Plus members.

Description:

Aim 1: To determine the extent to which contingent financial "treatment incentives" (i.e., incentives for biochemical verification visits, treatment engagement, and abstinence) versus "attendance incentives" (i.e., incentives for only attending the biochemical verification visits), increase rates of smoking cessation . Participants will be BadgerCare Plus tobacco users who enroll in Wisconsin Tobacco Quit Line (WTQL) services.

Aim 2: To determine the extent to which treatment incentives vs. attendance incentives increase rates of engagement in smoking cessation treatment through the WTQL when offered to BadgerCare Plus members who smoke.

Aim 3: To determine the cost‐effectiveness of the smoking cessation program when paired with treatment incentives and when paired with attendance incentives.

Aim 4: To identify moderating and mediational effects regarding the clinical benefit of incentivized smoking treatment

Aim 5: To determine the reach of an incentivized smoking cessation treatment that depends upon primary care clinic staff, a fax‐to‐quit referral mechanism and a state quit line.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• enrollment in Wisconsin Medicaid (BadgerCare Plus)

• resides in study area (one of 25 counties)

• member of participating HMOs

• 18 or older

• English speaking

• has smoked daily (at least 5 cigarettes each day) over the last week

• willingness to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls

• willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.

Exclusion Criteria:

• not enrolled in Wisconsin Medicaid (BadgerCare Plus)

• not reside in study area

• not a member participating HMOs

• less than 18 years of age

• not English speaking

• does not smoke daily (at least 5 cigarettes each day) over the last week

• not willing to attend visits at his/her PCC (primary care clinic) every 6 months (3 times over a 12 month period), provide urine samples, and complete follow-up phone calls.

• not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Smoking Cessation
• Tobacco Use Disorder

Intervention

Behavioral:
• Incentives for abstinence and treatment engagement
Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
• Attendance incentive
Attendance Incentives - incentives for only attending the biochemical verification visits

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from smoking	The data will be the biochemically confirmed reports of abstinence for the past 7 days (i.e., 7-day point-prevalence abstinence)	Measured 6 months after enrollment at follow-up assessment	No
Secondary	Engagement in treatment	The primary analyses will compare number of calls completed	Measured 12 months after enrollment at follow-up assessment	No
Secondary	Cost-effectiveness	The primary analysis will contrast the incremental costs of the treatment vs. attendance conditions by computing the Incremental Cost-Effectiveness Ratio (ICER) with regard to attaining 6-month abstinence.	Measured 12 months after enrollment	No